NCT05143164

Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Study of Hydrocolloid Dressing for Peritoneal Dialysis Catheter Exit Site Care in Peritoneal Dialysis Patients - a Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. It is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients.

Detailed description

Peritoneal dialysis (PD) related infection is one of the main reasons for patients to discontinue PD therapy. Routine exit-site care is crucial for the prevention of infections, however, daily antibiotics use has been associated with the risk of developing drug-resistant bacteria. Moreover, the burden of daily exit-site care can lead to non-compliance with treatment. Hydrocolloid dressing has been used in the management of acute and chronic wounds and is required to change once weekly, but its use has not been examined in the exit-site wound in PD patients. The study primarily aims to examine PD-related infection (exit site infection or peritonitis rates) between patients using weekly hydrocolloid dressing (experimental group) and those using daily topical application of gentamicin (control group) for exit-site care in PD patients. Secondary aims include time to the first episode of PD-related infection, technique failure, PD infection-related hospitalization, and adverse events. The study will also assess the acceptability of dressing and quality of life between the two groups. A total of 60 adult peritoneal dialysis patients will be recruited for the study. Patients will be randomly assigned to either the experimental group or the control group. Participants will be followed up at the 4th, 12th, and 24th week of study. The acceptability of the dressing will be assessed using the treatment acceptability questionnaires. The quality of life will be assessed using the ED 5D-5L questionnaires.

Conditions

• Peritoneal Dialysis Catheter Exit Site Infection

Interventions

Type	Name	Description
DEVICE	hydrocolloid dressing	Duoderm Extra Thin hydrocolloid dressing will be used to cover the catheter exit-site of participants in the intervention group. The dressing will be changed every 7 days or early if the dressing is no longer adhesive.
DRUG	Gentamicin Sulfate, Topical	Application of gentamicin to exit site daily

Timeline

• Start date: 2022-03-11
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2021-12-03
• Last updated: 2024-05-01

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated device study